MEDICAL REHABILITATION RESEARCH INFRASTRUCTURE RELEASE DATE: April 9, 2004 RFA NUMBER: RFA-HD-04-005 Update: The following update relating to this announcement has been issued: June 24, 2009 - This RFA has been reissued as (RFA-HD-09-013). EXPIRATION DATE: November 17, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865 LETTER OF INTENT RECEIPT DATE: October 18, 2004 APPLICATION RECEIPT DATE: November 16, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Child Health and Human Development (NICHD), through the National Center for Medical Rehabilitation Research (NCMRR), invites applications for grants to build research infrastructure by providing access to expertise, technologies, and resources from allied fields such as neurosciences, engineering, applied behavior, and the social sciences. Medical rehabilitation involves basic and clinical studies in the domains of pathophysiology, impairment, functional limitation, disability, and societal interaction. Increasingly, research breakthroughs and potential therapeutic strategies are the result of integrating expertise from allied fields as well as building up a core understanding of rehabilitative mechanisms and clinical outcomes. Access to technologies and approaches from allied fields is key to promoting multidisciplinary collaborations and developing research opportunities. Centralized research infrastructure will enhance the capability of medical rehabilitation investigators to understand mechanisms of functional recovery, develop therapeutic strategies, and improve the lives of people with disabilities. The aim of this Request for Applications (RFA) is to create a national network of research cores that will provide access to collateral expertise in biomedical, behavioral, and/or psychosocial fields that is particularly relevant to current opportunities in medical rehabilitation research. Applicants should propose a program of training, research resources, and collaborative opportunities in a specific content area. This may be accomplished through a combination of didactic interactions (workshops, courses, written material, and websites), consultations, sabbatical opportunities, and pilot funding. In addition, the research core may support intramural activities related to technique development, adaptation, and validation. Although examples of relevant expertise and content are provided below, additional areas may be proposed provided they are complementary to what is typically available in rehabilitation-related departments and appropriate for promoting medical rehabilitation research and improving outcomes. To aid potential applicants, a special website has been established to address administrative or logistical issues and to respond to frequently asked questions (FAQs). Potential applicants are encouraged to consult this website (http://www.nichd.nih.gov/RFA/HD-04-005/HD-04-005.htm) for additional information. RESEARCH OBJECTIVES Background The mission of the NCMRR is to enhance the quality of life for people with disabilities through research (NCMRR website available at http://www.nichd.nih.gov/about/ncmrr/ncmrr.htm). The NCMRR provides support for scientists to conduct research on impairments and functional changes associated with chronic physical conditions as well as rehabilitative strategies to reduce disability, improve health, and increase participation. Relevant conditions include stroke, brain or spinal cord injury, orthopedic injuries, developmental and degenerative disorders, and other chronic conditions. Investigations supported by NCMRR attempt to promote improvement at many levels: from reducing pathophysiology and physical impairment, to enhancing functional adaptation, to reducing disability and societal barriers. This requires an integration of biological, engineering, and sociobehavioral approaches to understand the basis of the chronic condition, secondary implications, and the interaction of the individual with his/her environment. A multidisciplinary approach to these goals is fundamental to medical rehabilitation practice. In 1999, the NCMRR solicited applications for four regional research networks to promote resources, information, and networking in order to expand the capabilities and numbers of investigators who pursue research in medical rehabilitation. The current RFA represents the next step in that process, with more of a focus on providing national access to specific expertise and research resources. Scientific opportunities have emerged in many areas relevant to medical rehabilitation with the potential for: (1) improving our understanding of pathological processes and secondary complications; (2) promoting plasticity, recovery, and adaptation; (3) developing assistive technologies and engineering solutions; (4) understanding the role of family, community, and other environmental factors; and (5) providing long-term treatments to reduce disability and promote health and well-being. Centralized research infrastructure will not only increase access to resources and expertise, but will also promote collaborations among rehabilitation researchers, clinicians, and investigators from allied fields. Scope The purpose of the national medical rehabilitation research infrastructure program is to provide access to specialized expertise and resources not typically available to rehabilitation-related research departments. This includes the introduction from allied fields of cutting-edge technologies and approaches that are particularly timely for understanding physiological and psychosocial processes and promoting rehabilitative outcomes. The emphasis should be on approaches that are relevant to current opportunities in medical rehabilitation research and those that can be transmitted through a concerted program of didactic and collaborative interactions. The aim of this RFA is to create a national network of medical rehabilitation research infrastructure cores that will provide access to collateral expertise that is particularly relevant to current opportunities in medical rehabilitation research. Applicants should propose a program of training, research resources, and collaborative opportunities in a specific content area. Although examples of relevant expertise and content are provided below, additional areas may be proposed provided they are complementary to what is typically available in rehabilitation-related departments and appropriate for promoting medical rehabilitation research and improving outcomes. Examples of possible cores include, but are not limited to: o Molecular, cellular, and/or biophysical support of plasticity and recovery of function: Neuroplasticity (tissue interactions, neurotrophic factors, extracellular matrix); cellular and gene therapies; implants and (chronic) delivery systems; biophysical, electrical, and activity-driven mechanisms; angiogenesis and support of tissue function. o Rehabilitation engineering: Orthotics and prosthetics; robotics; assistive technologies; bowel and bladder function; remote sensing; environmental control; enhancing access and participation. o Biomaterials: Biocompatibility and tissue interactions; tissue replacements; electrical and computer implants; nanotechnology. o Applied behavior and psychosocial support: Behavioral/social/emotional aspects of chronic disabilities; longitudinal study design; enhancing compliance and health-promoting activities; ecological validity; transfer of clinical therapies to community settings; support of telemedicine; health services research. o Imaging technologies: Anatomical and biochemical approaches (e.g., PET, SPECT, NIRS); functional approaches (e.g., fMRI, EEG/MEG, TES/TMS); imaging non-neuronal tissues (skin, bone, muscle) o Pharmacological approaches: Mechanisms of drug actions (e.g., pain management, enhancing sensory and motoric function, treating cognitive and behavioral deficits); pharmacokinetics; studies of chronic treatments and drug interactions; safety and efficacy studies; clinical trial design. o Animal models: Understanding pathophysiological processes, adaptation, and recovery; functional consequences of anatomical abnormalities; motor and behavioral testing; evaluating therapeutic interventions and chronic treatments; extrapolating animal results to human conditions. A national medical rehabilitation research infrastructure core will have the following responsibilities: o Courses, workshops, demonstrations, and other didactic programs: These may occur at the applicant institution or at national meetings, as appropriate. When possible, activities should be available for remote viewing and archived for possible screening at a later date. o Website and a library of research resources: The core should develop research manuals, background information, reference articles, databases, contact information, and other research resources. The core is also responsible for providing access to consultative services and expertise, as appropriate. o Pilot studies: Each infrastructure program may set aside pilot funds up to $150,000 per year (direct costs) to support small research studies by qualified investigators who are accessing core resources. There should be a formal process to solicit and review pilot proposals, and evaluate their potential to develop into successful NIH applications. Researchers associated with the infrastructure grant may be considered for pilot funding, but first priority should be researchers from other locations. o Sabbatical and collaborative opportunities: The core should provide opportunities for visiting rehabilitation investigators to work with experts at the grantee institution, as appropriate. There should be a formal plan for promoting and supporting a limited number of sabbatical interactions that provide hands-on research experience and collaboration. It is expected that the home institution of the visiting investigator will share substantial responsibility for financial support of the candidate's extended visit. o Techniques development: Research cores may propose intramural activities to further develop, adapt, and/or validate core research techniques, tools or other resources. Up to $150,000 per year (direct costs) may be directed toward these activities provided they are focused on improving access, utility, and validity of these approaches for the medical rehabilitation research community. o Promoting expertise in the rehabilitation research community: The core has the responsibility to make its activities, resources, and opportunities known to the basic and clinical rehabilitation research community. This may be accomplished through some combination of advertisements in professional journals, newsletters and websites; contacts with relevant research departments and funded researchers; presentations at professional meetings; and other means, as appropriate. o Administrative oversight: The research core must develop formal plans for prioritization of resources, access guidelines, quality control, responsiveness to the research community, and documentation of overall effectiveness. Oversight must include the use of an external advisory board. o Subcontracts may be used to provide access to key expertise or resources essential for the overall goals of the research core. MECHANISM OF SUPPORT This RFA will use the NIH Resource-Related Research Project (R24) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is July 01, 2005. FUNDS AVAILABLE The NICHD intends to commit approximately $4 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2005 to support three to five new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $700,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions/organizations. Foreign institutions are not eligible to apply. Only institutions located within the boundaries of the United States and its territories may apply for support under this RFA. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Ralph Nitkin, Ph.D. Biological Sciences and Career Development National Institute of Child Health and Human Development 6100 Executive Boulevard, 2A03, MSC 7510 Bethesda, MD 20852-7510 Telephone: (301) 402-4206 FAX: (301) 402-0832 Email: firstname.lastname@example.org o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: email@example.com o Direct your questions about financial or grants management matters to: Christopher Robey Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6996 FAX: (301) 480-4783 Email: firstname.lastname@example.org LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Ralph Nitkin, Ph.D. Biological Sciences and Career Development Program National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, 2A03, MSC 7510 Bethesda, MD 20852-7510 Telephone: (301) 402-4206 FAX: (301) 402-0832 Email: email@example.com SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: Instructions accompanying the PHS 398 form should be followed. In the Research Plan section, applications for Medical Rehabilitation Research Infrastructure grants should address the following: Introductory Overview and Core Description (no more than 10 pages) Discuss the philosophy, objectives, and potential impact on medical rehabilitation research of the proposed research core. Describe how it builds on resources and expertise of the applicant institution. Provide some background on the broader field(s) of expertise involved, including recent advances, limitations, and overall impact on biomedical research. Make clear why this expertise would be particularly appropriate and timely for medical rehabilitation researchers. Describe the scope of the research core proposed, including the techniques, approaches, resources, and opportunities that it will provide to the rehabilitation community. Indicate which rehabilitation researchers would be the primary target(s) of this core and what sort of background would be required to take advantage of these opportunities. Indicate how readily this expertise or technology could eventually be franchised out to interested researchers and their departments. Didactic Interactions (no more than 15 pages) Describe the specific mix of courses, conferences, and workshops proposed. For each activity, provide details on content, format, relevant expertise and resources, target audience, and planned venue. Discuss how often these activities will be offered and how they will be promoted and evaluated. Describe the development of a website and distribution of written material (e.g., manuals, references, contacts, and databases). Provide details on access to supplementary consultative services and expertise. Pilot Projects and Sabbatical Opportunities (no more than 10 pages) Provide a plan for soliciting and evaluating requests for pilot funding and sabbatical interactions. Include details on eligibility criteria, evaluation, prioritization, and administration of funds. Discuss laboratories and projects that could offer sabbatical and collaborative opportunities and how these interactions would be sustained (i.e., potential benefits to the host laboratory or project that sponsors such interactions and the appropriate time commitments required). Discuss how the logistics of a sabbatical would be negotiated with the home institution of the visiting researcher. Technology Development (no more than 5 pages) Describe the state of the technologies proposed and whether further modification would be required and/or warranted. Discuss plans for technology development, adaptation, and validation to better serve the rehabilitation research community. This may include plans to modify technologies and resources to make them more appropriate for specific clinical conditions, populations (e.g., children or minorities), or other specialized applications. Some validation studies may be appropriate, but large-scale studies and clinical trials are beyond the scope of these infrastructure grants and should be supported by other means. Key Personnel (no more than 5 pages) Describe the role of key scientific and administrative personnel. Include sufficient background on their scientific expertise, research experience, and commitment to the infrastructure activities. Administrative Oversight (no more than 10 pages) Describe the administrative organization of the research infrastructure core. Include plans to interface with the medical rehabilitation research community, promote access to resources, deal with competing demands on facilities, evaluate quality control, improve responsiveness, and document overall effectiveness and impact on medical rehabilitation. Include plans for an independent advisory board to provide guidance on resources, didactic interactions, and interactions with the medical rehabilitation community (do not propose specific advisory board members at this time, but indicate the types of people who would be appropriate for these roles). USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA The goal of this program is to develop research infrastructure to advance our understanding of biological systems, interactions with the environment, and other psychosocial processes that contribute to improving function, reducing secondary consequences and disability, and promoting participation and overall quality of life for persons with chronic physical disabilities. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals, particularly in the area of medical rehabilitation: o QUALITY OF EXPERTISE AND RESOURCES: Qualifications of the applicants in the proposed content area and the availability of appropriate resources. This may include access to unique resources, equipment, expertise, or patient populations. o COMMITMENT OF KEY PERSONNEL: Adequacy of their commitment to the core research mission and their ability to devote the required time and effort to the program. o POTENTIAL OF THE PROPOSED CONTENT AREA to further medical rehabilitation and respond to the needs of the research community. o POTENTIAL FOR TRANSMITTING EXPERTISE to the rehabilitation research community through didactic interactions, research collaborations, and resource infrastructure. o OPPORTUNITIES FOR SABBATICAL INTERACTIONS AND OTHER COLLABORATIONS at the applicant site. o Where applicable, CORE PLANS TO FURTHER DEVELOP, ADAPT, MODIFY, AND/OR VALIDATE the technologies and expertise available to the medical rehabilitation community. o OVERALL ADMINISTRATION: Strength of the plans for promoting access, prioritization of demands on core resources, quality control, administration of pilot funds, responsiveness to the medical rehabilitation research community, and documentation of research support and overall effectiveness. o INSTITUTIONAL SUPPORT AND OTHER RESOURCES: Documentation of institutional support and adequacy of resources available to enhance the functioning of the research core, especially the leveraging of funds and connection to additional resources and opportunities. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 18, 2004 Application Receipt Date: November 16, 2004 Peer Review Date: March 2005 Council Review: June 2005 Earliest Anticipated Start Date: July 01, 2005 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities o Uniqueness of proposed core (it is possible that two cores with similar content areas will be funded depending on the uniqueness of their approaches and the overall distribution of meritorious applications). REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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